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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036186
Receipt No. R000041228
Scientific Title Acquisitions of image data for visual diagnosis by specialists and sensor data on gait and falls in elderly people.
Date of disclosure of the study information 2019/03/18
Last modified on 2019/04/03

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Basic information
Public title Acquisitions of image data for visual diagnosis by specialists and sensor data on gait and falls in elderly people.
Acronym Acquisitions of gait data from wearable foot sensor and gait images for visual diagnosis.
Scientific Title Acquisitions of image data for visual diagnosis by specialists and sensor data on gait and falls in elderly people.
Scientific Title:Acronym Acquisitions of gait data from wearable foot sensor and gait images for visual diagnosis.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed at understanding the relationship between the gait of elderly people and the probability of their future falls by acquiring gait data and gait images for visual diagnosis by specialists, for the purpose of encouraging nursing home users to change behaviors to prevent falls.
Basic objectives2 Others
Basic objectives -Others Research
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1. Gait acquired from a wearable foot sensor and images
2. Modified Gait Abnormality Rating Scale (GARS-M)
3. 5-question Geriatric Locomotive Function Scale
4. Survey of the history of falls
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 We measure foot pressure, foot deformity, and change in acceleration during gate by using wearable foot sensor and conduct upright posture and gait measurements.
We capture a video of walking and make a visual diagnosis of gait using the GARS-M.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. 65 years old or older (at the time of submission of an informed consent document).
2. Males and females.
3. Those who can walk independently.
4. Those who can provide a written informed consent.
Key exclusion criteria 1. Those who seem to have communication difficulties (such as dementia and mental disorders).
2. Those who were determined to be unsuitable for participation in this clinical trial, in the opinion of the principal investigator.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Takuji
Middle name
Last name Nomura
Organization KANEKA Corporation
Division name New Business Development Division (Planning)
Zip code 530-8288
Address 2-3-18,Nakanoshima,Kita-ku, Osaka,Japan
TEL 050-3133-6566
Email Takuji.Nomura@kaneka.co.jp

Public contact
Name of contact person
1st name Tomo
Middle name
Last name Hirose
Organization KANEKA Corporation
Division name New Business Development Division (Planning)
Zip code 530-8288
Address 2-3-18,Nakanoshima,Kita-ku, Osaka,Japan
TEL 050-3133-7483
Homepage URL
Email Tomo.Hirose@kaneka.co.jp

Sponsor
Institute KANEKA Corporation
Institute
Department

Funding Source
Organization KANEKA Corporation
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Prefectural University of Hiroshima
Hiroshima Prefectural Technology Research Institute
Name of secondary funder(s)

IRB Contact (For public release)
Organization Suda Clinic institutional review board
Address 2-8-14, Takadanobaba, Shinjyuku, Tokyo, Japan
Tel 03-6205-6222
Email suda-clinic_irb@imeq.co.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 練馬区coconeriホール
Nerima-ku Coconeri hall

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2019 Year 01 Month 22 Day
Date of IRB
2019 Year 02 Month 26 Day
Anticipated trial start date
2019 Year 03 Month 19 Day
Last follow-up date
2021 Year 03 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 13 Day
Last modified on
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041228

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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